Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 2:07 PM
Ignite Modification Date: 2025-12-25 @ 12:49 PM
NCT ID: NCT00265395
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00265395
Study Brief: Extended Treatment With PEG-Intron® and Rebetol® in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Therapy (48-week Treatment) None None None 93 1427 1337 1427 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
PANCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
ATRIOVENTRICULAR BLOCK COMPLETE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
ATRIOVENTRICULAR BLOCK SECOND DEGREE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
PALPITATIONS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
PERICARDIAL EFFUSION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
SINUS BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.0 View
AUTOIMMUNE THYROIDITIS SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.0 View
HYPERTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.0 View
HYPOTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.0 View
THYROIDITIS SUBACUTE SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.0 View
RETINAL DETACHMENT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
RETINAL TEAR SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
VISUAL DISTURBANCE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
ABDOMINAL PAIN LOWER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
COLITIS ULCERATIVE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
GASTRITIS EROSIVE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
INTUSSUSCEPTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
PANCREATITIS NECROTISING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
SMALL INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
VOLVULUS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
CHOLECYSTITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
CHOLECYSTITIS ACUTE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
JAUNDICE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.0 View
CYTOMEGALOVIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
INJECTION SITE ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
INJECTION SITE CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
LOBAR PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
ORCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PULMONARY TUBERCULOSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
SALMONELLOSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
SEPTIC SHOCK SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
SYPHILIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
ALCOHOL POISONING SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
CLAVICLE FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
CONCUSSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
MULTIPLE DRUG OVERDOSE INTENTIONAL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
ROAD TRAFFIC ACCIDENT SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
SCAPULA FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
UPPER LIMB FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
ARTERIOGRAM SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
HEART RATE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
PLATELET COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
WHITE BLOOD CELL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
HYPERCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
HYPONATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
ARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
UNEQUAL LIMB LENGTH SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
CAROTID ARTERY DISSECTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
CAROTID ARTERY OCCLUSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
CEREBRAL INFARCTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
CONVULSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
EPILEPSY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
GRAND MAL CONVULSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
MEMORY IMPAIRMENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
MIGRAINE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
NERVOUS SYSTEM DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
PARKINSONISM SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
SYNCOPE VASOVAGAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
TREMOR SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
ABORTION SPONTANEOUS SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 10.0 View
ALCOHOLISM SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
HALLUCINATION, AUDITORY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
HALLUCINATION, VISUAL SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
HOMICIDAL IDEATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
OBLITERATIVE BRONCHIOLITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
ECZEMA NUMMULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
SKIN LESION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
ANAL FISSURE EXCISION SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 10.0 View
THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
CERVIX CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
HEPATIC NEOPLASM MALIGNANT SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
PARATHYROID TUMOUR BENIGN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
UTERINE LEIOMYOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
BIPOLAR DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
COMPLETED SUICIDE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
DELIRIUM SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
PANIC ATTACK SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
PARANOIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
PSYCHOTIC DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
SUICIDAL IDEATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
SUICIDE ATTEMPT SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
OLIGURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
METRORRHAGIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
BRONCHITIS CHRONIC SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
DYSPNOEA EXERTIONAL SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
HAEMOPNEUMOTHORAX SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
HAEMOPTYSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
INTERSTITIAL LUNG DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
ABSCESS LIMB SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
ABSCESS ORAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
DISLOCATION OF VERTEBRA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
DRUG TOXICITY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
ERYTHROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
INJECTION SITE ERYTHEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
IRRITABILITY SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
HAEMOGLOBIN DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
NEUTROPHIL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
WHITE BLOOD CELL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
ANOREXIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
DISTURBANCE IN ATTENTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View